Thursday, February 7, 2013

FISSION Study Should Support Regulatory Approval For Gilead's Hepatitis C Drug

Related @ HIV and Hepatitis
Feb 6 - Sofosbuvir Combos Match or Beat Standard Hepatitis C Therapy For All Genotypes

Press Release
Feb 4 - Gilead Announces SVR Rates from Two Phase 3 Studies of Sofosbuvir (GS-7977) for Hepatitis C

Investment commentary

FISSION Study Should Support Regulatory Approval For Gilead's Hepatitis C Drug

By Amit Cohen
Gilead Sciences (GILD) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
On Monday, Gilead announced positive top‐line results from two Phase III studies (FISSION and NEUTRINO) that involve the use of sofosbuvir in combination with other agents for use in treatment‐naïve patients infected with the Hepatitis C virus (HCV).
The FISSION study enrolled approximately 500 treatment-naïve patients with HCV genotype 2 or 3 (at a 1:3 ratio) and evaluated the safety and efficacy of 12 weeks of GS-7977 + RBV vs. 24 weeks of PEG-IFN and RBV. The primary endpoint of the trial is SVR12 (sustained viral response at week 12 after treatment is completed). FISSION was a non-inferiority trial in which the bottom end of the 95% confidence interval of sofosbuvir's SVR rate had to be within 15% of the SVR rate of PEG-IFN. With the weakest part of sofosbuvir's profile being its activity in GT 3 patients, and a 3:1 ratio of GT 3 vs GT 2 in the study, there was some chance that the noninferiority margin could have been missed. In fact, the expectations for FISSION had come down significantly after the release of POSITRON data during Q4:12. In POSITRON sofosbuvir + RBV produced SVR rates of 93% in genotype 2 patients and 61% in genotype 3 patients....

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